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Introduction to Datamonitor About Healthcare TABLE OF CONTENTS EXECUTIVE SUMMARY Patient potential in hepatitis Unmet needs in hepatitis Investors in hepatitis Class focus Future market leaders R&D opportunities in hepatitis DISEASE OVERVIEW Definition of disease Hepatitis B Hepatitis C Patient potential Hepatitis B Hepatitis C Classification of pipeline products Interferons Nucleoside analogues Antisense oligonucleotides Ribozymes Immune response modifiers and therapeutic vaccines Vaccines Clinical endpoints in disease Liver Histology Viral clearance Seroconversion ALT levels Unmet needs in hepatitis Greater efficacy of treatment Lack of vaccines for hepatitis C Combination treatment to prevent resistance Increased awareness Shorter dosing period Less expensive therapy Orally administered products Benefits for patients co-infected with HIV Lack of second line treatment options Improved safety profile HEPATITIS PIPELINE ANALYSIS Pipeline analysis by development strategy Key drug discovery strategies in hepatitis Key R&D protocol strategies in hepatitis Key marketing strategies in hepatitis Key licensing strategies in hepatitis Pipeline analysis by class Hepatitis B Hepatitis C Pipeline analysis by region Hepatitis B Hepatitis C Pipeline analysis by company type Hepatitis B Hepatitis C HBV DRUG ANALYSIS Key Vaccines Hepacare (formerly Hepagene) Advanced Engerix-B vaccine/SBAS4 adjuvant Corixa's MPL adjuvant is a derivative of the lipid A molecule with potent immunostimulatory effect. Corixa extracts the MPL adjuvant from the cell walls of gram-negative bacteria. This Lipid A based product improves humoral as well as cellular immune responses through its ability to activate macrophages. Nucleoside analogs Preveon - Adefovir dipipvoxil (GS 840) Coviracil (FTCB-301) Entecavir (BMS 200475) Famvir (famciclovir) Therapeutic vaccines HBV vaccine/MF59 adjuvant Innovative early stage projects EHT 899 Edible Potato vaccine The Boyce Thompson Institute for Plant Research Inc. at Cornell University is developing an oral prophylactic vaccine. This will be delivered by eating genetically engineered potatoes that produce the vaccine in their flesh. The current hepatitis B vaccine is based on the HBsAg antigen, which is produced in yeast. The new product closely resembles the yeast vaccine but it would be cheaper and would not require injection or refrigeration, making distribution easier. However, a commercial partner is essential to the development of the project, following their partner, Axis Genetics Plc, going into administration amid European fears about genetically engineered foods. Companies have the opportunity to negotiate a financial interest in this promising project and to capitalize on its future worldwide sales. The current hepatitis B vaccine generates profits of $1 billion a year and a plant-derived alternative could capture a significant share of this market DNA Vaccine - PowderJect technology XTL-001 XTL Biopharmaceuticals Ltd. is developing human monoclonal antibody therapies for hepatitis. XTL-001 is a product that has been shown to rapidly and consistently decrease HBV-DNA and HBsAg levels without inducing serious adverse events. A phase I trial of twelve chronic HBV infected patients that received multiple infusions of XTL-001 over four consecutive weeks has encouraged development to phase II therapeutic studies in combination with lamivudine. MCC-478 Eli Lilly in-licensed MCC-478, a novel antiviral agent for the treatment of hepatitis B from Mitsubishi-Tokyo Pharmaceuticals in December 2000. Lilly purchased exclusive rights to develop and market this compound worldwide, excluding Japan. Phase I that the course of therapy for this nucleoside analog prodrug may be shorter human clinical trials suggest that MCC-478 has a potent and selective activity against HBV and than for current therapies. HepBzyme Recently discontinued projects Lobucavir (BMS 10981194) Theradigm HCV DRUG ANALYSIS Immune response modifiers Maxamine Maxim expects to conduct its phase III studies under a comprehensive development collaboration with Roche. The collaboration program will include two phase III trials of the Maxamine, Pegasys and Rebetol combination for the treatment of hepatitis C, one in naïve patients and one in patients who were non-responsive to prior therapy. The clinical development and approval of Maxamine in combination with Roche's Pegasys will drive the uptake of these products in competition to Schering-Plough's Peg-Intron in combination with Rebetol. Macrokine (WF10) Resiquimod (VML 600) VX 497 Other pipeline products IP 501 Retrovir (zidovudine) Symmetrel (amantidine) Monotherapy: Symmetrel Combination therapy: Symmetrel + interferon Combination therapy: Symmetrel + interferon + Rebetol Endo Pharmaceuticals has a focus on pain management although its portfolio also includes branded products for coughs and colds. Success with Symmetrel would provide the company with significant opportunities which may be limited by their 100-strong field sales team. Heptazyme (LY466700) HCV Vaccine/MF59 adjuvant Urso (ursodiol) Marketing factors Urso promises few advantages over current treatments and has little sales potential. Hep C Hyperimmune Innovative early stage projects Levovirin ISIS 14803 Tenovil (interleukin-10 ) Viramidine COMPARATIVE ANALYSIS OF HBV PIPELINE Comparison of therapeutic drug classes Efficacy Dosing Patient potential Overall performance Comparative analysis of nucleoside analogs Comparison of efficacy of nucleoside analogs Comparison of dosing schedules of nucleoside analogs Comparison of patient potential of nucleoside analogs Overall comparison of nucleoside analogs Comparative analysis of prophylactic vaccines Comparison of efficacy of prophylactic vaccines Comparison of dosing schedules of prophylactic vaccines Comparison of patient potential of prophylactic vaccines Overall comparison of prophylactic vaccines COMPARATIVE ANALYSIS OF HCV PIPELINE Comparison by class Efficacy Dosing Patient group Overall performance Comparative analysis of the immune modifiers Comparison of efficacy of the immune modifiers Comparison of dosing schedules of immune modifiers Comparison of patient potential of immune modifiers Overall comparison of the immune modifiers Comparative analysis of the other anti-HCV pipeline products Comparison of efficacy of the other anti-HCV pipeline products Comparison of dosing schedules of other anti-HCV pipeline products Comparison of patient potential of other anti-HCV pipeline products Overall comparison of other anti-HCV pipeline products FUTURE FOCUS IN HEPATITIS Future incidence and prevalence of hepatitis Prospective anti-hepatitis drug launches Launch forecast methodology Forecast launches of hepatitis therapeutics, to 2008 Antibacterial Market Forecasts, (2001-2008) Forecast methodology Hepatitis Treatment Market Forecasts Factors Influencing the Hepatitis Treatment Market (2001-2008) Trends in the global hepatitis treatment market to 2008 Key R&D therapeutic product forecasts Therapeutic pipeline product forecasts by class Nucleoside analog product forecasts Immune modifier product forecasts Therapeutic vaccines product forecasts Other anti-HCV product forecasts Hepatitis B Vaccine Market Forecasts Factors affecting the future hepatitis B vaccine market Trends in the global hepatitis B vaccine market to 2008 Hepatitis B vaccine product forecasts APPENDIX Research programme methodology SPRINT databases Primary research Quantification of data reliability Forecasting methdology The forecasting methodology is explained in the forecasting section of the report. LIST OF TABLES LIST OF FIGURES